Phase 2 Kidney Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have signed a consent form and are willing and able to follow the study requirements
• People aged 18 years or older
• People with a life expectancy of more than 12 weeks
• People who have no symptoms from their brain cancer, or only mild symptoms that do not affect their ability to carry out daily activities, and who have not needed steroid medicines for at least 10 days
• People who have previously received treatment for kidney cancer that had spread outside the brain, as long as that treatment did not include anti-CTLA-4 therapy, cabozantinib, or MET inhibitors
• People with kidney cancer that has spread to the brain, confirmed by a tissue sample (biopsy), with at least one measurable brain tumour between 5mm and 30mm in size on an MRI scan with contrast, that has either not been treated before or has grown after previous local treatment (such as targeted radiation or surgery), and for which immediate local treatment is not currently recommended or suitable
• People whose blood and organ function tests, taken within 14 days before starting treatment, meet specific levels for blood cells, liver function, kidney function, and protein in the urine (confirm specific values with the trial site)
• People with a general physical ability score of 0 to 2 on the ECOG scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose blood clotting test results are within an acceptable range, taken within 7 days before joining
• People whose side effects from any previous treatments have returned to near-normal or mild levels before starting the trial
• People of childbearing potential, and male participants whose partners could become pregnant, who agree to use highly effective contraception during the trial and for at least 12 months after the last dose of study treatment

Who may not be able to join:

• People whose brain tumours are causing significant symptoms and require immediate treatment such as surgery or radiation
• People whose cancer outside the brain requires immediate surgery or radiation
• People who have had radiation therapy to bones within the past 2 weeks, any other radiation therapy within the past 4 weeks, or radioactive drug treatments within the past 6 weeks — or who have ongoing complications from previous radiation
• People who have needed corticosteroid (steroid) medicines in the 10 days before starting treatment, unless their steroid dose has been stable or decreasing during that time due to mild brain tumour symptoms
• People whose cancer has spread to the lining surrounding the brain and spinal cord (leptomeningeal disease)
• People who have received anticancer treatments within 4 weeks before starting the trial (some exceptions apply, such as hormone replacement therapy or oral contraceptives — confirm with trial site)
• People currently taking part in, or who have recently participated in (within 3 weeks), or who plan to join another experimental drug study
• People who still have side effects from previous cancer treatment that have not improved to a mild level, except for hair loss
• People with significant active liver disease, such as active viral hepatitis, alcoholic liver disease, or advanced cirrhosis
• People with certain types of blood cancers, such as acute leukaemia or Burkitt lymphoma (confirm full list with trial site)
• People who are pregnant, breastfeeding, or currently lactating
• People with a known allergy to recombinant human antibody medicines
• People who are unable to have an MRI scan due to metal implants in their body or an allergy to the contrast dye used in MRI
• People who are unable to follow the study procedures and attend follow-up appointments
• People with a history of autoimmune diseases (where the immune system attacks the body), such as lupus, rheumatoid arthritis, inflammatory bowel disease, or multiple sclerosis — though some exceptions may apply for people with well-controlled thyroid disease, well-controlled Type 1 diabetes, or certain mild skin conditions (confirm with trial site)
• People with a history of serious lung conditions such as pulmonary fibrosis, drug-induced lung inflammation, or active lung inflammation seen on a recent CT scan (some exceptions may apply — confirm with trial site)
• People with any other serious medical condition that could make study treatment unsafe or affect the results
• People with HIV infection, or active hepatitis B or C infection (some exceptions may apply for people with past resolved infections — confirm with trial site)
• People with active tuberculosis
• People who have had a serious infection requiring hospitalisation within 4 weeks before starting treatment
• People who have had signs or symptoms of any infection within 2 weeks before starting treatment
• People who have taken antibiotic medicines by mouth or through a drip within 2 weeks before starting treatment, unless they are taking antibiotics as a regular preventive measure (confirm with trial site)
• People who have received a live vaccine (such as a live flu vaccine) within 4 weeks before starting treatment, or who may need one during the study
• People who have had another cancer within the past 5 years, with some exceptions for certain low-risk or successfully treated cancers (confirm with trial site)
• People with a life expectancy of less than 12 weeks

Important: Always verify eligibility with the trial site directly before applying.